Comparison · NCT04444895-sae
Lanadelumab 300 mg Every 2 Weeks vs Lanadelumab 300 mg Every 4 Weeks: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Lanadelumab 300 mg Every 2 Weeks vs Lanadelumab 300 mg Every 4 Weeks: serious adverse events. Trial comparisons, record NCT04444895-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04444895-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0959 | 0.0472 | 0.185 | wilson | |
| Risk in group 2 | 0.5 | 0.0945 | 0.905 | wilson | |
| Risk difference, group 1 minus group 2 | -0.404 | -0.812 | 0.011 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.192 | 0.0405 | 0.908 | log | |
| Odds ratio, group 1 over group 2 | 0.106 | 0.00596 | 1.89 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Lanadelumab 300 mg Every 2 Weeks than on Lanadelumab 300 mg Every 4 Weeks | 2.47 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Lanadelumab 300 mg Every 2 Weeks | Participants received 300 mg lanadelumab SC injection, Q2W for up to 26 weeks with an option to switch to lanadelumab 300 mg Q4W if attacks were well-controlled based on the investigator's discretion and consultation with the sponsor's medical monitor. | 7 | 73 | EG000 |
| Group 2 | Lanadelumab 300 mg Every 4 Weeks | Participants who received 300 mg lanadelumab, SC injection, Q4W as attacks were well-controlled based on the investigator's discretion and consultation with the sponsor's medical monitor at any point during the 26-week treatment period were included in this group. | 1 | 2 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From the first study drug administration up to follow-up (Day 196)
Source ClinicalTrials.gov
Trial
- Title
- A Study of Long-Term Safety and Efficacy of Lanadelumab for Prevention of Acute Attacks of Non-histaminergic Angioedema With Normal C1-Inhibitor
- NCT number
- NCT04444895
- Phases
- PHASE3
- Conditions
- Angioedema
- Interventions
- Lanadelumab
- Lead sponsor
- Shire
- Results first posted
- 2024-06-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04444895?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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